当前位置: X-MOL 学术Pilot Feasibility Stud. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2019-09-07 , DOI: 10.1186/s40814-019-0490-x
Katrine Bostrøm 1, 2 , Sverre Mæhlum 1 , Milada Cvancarova Småstuen 3, 4 , Kjersti Storheim 3, 4
Affiliation  

Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatment of LE in terms of pain relief. The primary objective of this pilot trial was to assess the feasibility (retention and adherence rates) of performing a randomized controlled trial (RCT) to explore the clinical effectiveness of acupuncture and manual therapy treatment of LE. This pilot trial took place in an outpatient interdisciplinary institute of sports medicine and rehabilitation in Oslo, Norway. Thirty-six adults with clinically diagnosed LE were randomly allocated into one of three groups: eccentric exercise alone, eccentric exercise plus acupuncture, or eccentric exercise plus manual therapy for a 12-week treatment period. Primary outcomes were patient retention and adherence rates. Secondary outcomes included patient-reported pain (NRS), level of disability (Quick-DASH), and participant’s satisfaction with treatment and global perceived effect. Nine (69%) patients in the acupuncture group completed the 1-year follow-up, compared to eight (67%) in the manual therapy group and five (45%) in exercise alone. Our goal was to demonstrate a retention rate above 80% to avoid serious threats to validity, but the result was lower than expected. The majority of participants (64%) in both treatment groups received only three-treatment sessions; the reasons included non-attendance or recovery from pain. Secondary outcomes support the rationale for conduction of an RCT. There were no adverse advents related to study participation. Based on differences in pain relief between groups, patient retention, and adherence rates, an RCT seems to be feasible to assess treatment effectiveness more precisely. In a future definitive trial, greater dropout may be reduced by maintaining contact with the participants in the exercise alone group throughout the intervention, and objective assessments might be considered. ClinicalTrials.gov, NCT02321696

中文翻译:

针灸与手法治疗外上髁炎临床疗效比较:可行性随机临床试验

外上髁炎 (LE) 对临床医生来说是一种具有挑战性的疾病,研究尚未证明一种特定治疗方法的优越性。然而,已经发现除了离心运动之外的手法治疗(肘部活动)优于单独运动。同样,与假治疗相比,针灸在短期缓解疼痛方面有效,但关于手法治疗和针灸治疗 LE 在缓解疼痛方面的比较效果知之甚少。该试点试验的主要目的是评估进行随机对照试验 (RCT) 以探索针灸和手法治疗 LE 的临床有效性的可行性(保留率和依从率)。该试点试验在挪威奥斯陆的一个门诊跨学科运动医学和康复研究所进行。36 名临床诊断为 LE 的成年人被随机分配到三组中的一组:单独离心运动、离心运动加针灸或离心运动加手法治疗,治疗期为 12 周。主要结果是患者保留率和依从率。次要结果包括患者报告的疼痛 (NRS)、残疾程度 (Quick-DASH) 以及参与者对治疗和整体感知效果的满意度。针灸组 9 名 (69%) 患者完成了 1 年的随访,而手法治疗组 8 名 (67%) 患者和单独运动组 5 名 (45%) 患者完成了随访。我们的目标是证明保留率高于 80%,以避免对有效性的严重威胁,但结果低于预期。两个治疗组的大多数参与者 (64%) 只接受了 3 次治疗;原因包括不出席或从疼痛中恢复。次要结果支持进行 RCT 的基本原理。没有与研究参与有关的不良事件。基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 两个治疗组的大多数参与者 (64%) 只接受了 3 次治疗;原因包括不出席或从疼痛中恢复。次要结果支持进行 RCT 的基本原理。没有与研究参与有关的不良事件。基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 两个治疗组的大多数参与者 (64%) 只接受了 3 次治疗;原因包括不出席或从疼痛中恢复。次要结果支持进行 RCT 的基本原理。没有与研究参与有关的不良事件。基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 原因包括不出席或从疼痛中恢复。次要结果支持进行 RCT 的基本原理。没有与研究参与有关的不良事件。基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 原因包括不出席或从疼痛中恢复。次要结果支持进行 RCT 的基本原理。没有与研究参与有关的不良事件。基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696 基于组间疼痛缓解、患者保留率和依从率的差异,RCT 似乎可以更准确地评估治疗效果。在未来的最终试验中,通过在整个干预过程中与单独锻炼组的参与者保持联系,可以减少更大的辍学率,并且可以考虑进行客观评估。ClinicalTrials.gov,NCT02321696
更新日期:2019-09-07
down
wechat
bug